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Hope for rare Muscle-Weakening disease: new drug trial targets Antibody-Negative patients

NCT ID NCT06298552

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests an investigational drug called efgartigimod, given intravenously, for adults with generalized myasthenia gravis (gMG) who do not have the typical acetylcholine receptor antibodies. The trial compares the drug to a placebo to see if it improves daily activities and muscle strength. About 119 participants will be followed for up to 2.5 years, with all eligible participants receiving the drug in the second part of the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

119 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The participant is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. * The participant is capable of providing signed informed consent and following with protocol requirements. * The participant agrees to use contraceptive measures consistent with local regulations and the women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline before receiving the study drug. * The participant has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG of both of the following: 1. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation (RNS) or is for anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive 2. Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment * The participant is receiving a stable dose of MG therapy before screening, including acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidal immunosuppressive therapies (NSISTs) in combination or alone Exclusion Criteria: * Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or puts the participant at undue risk * History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer * Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV * History of or current alcohol, drug, or medication abuse as assessed by the investigator * Pregnant or lactating state or intention to become pregnant during the study * Live or live-attenuated vaccine received \<4 weeks before screening * Worsening muscle weakness secondary to concurrent infections or medications * Received a thymectomy less than 3 months before screening or thymectomy is planned during the study The complete list of exclusion criteria can be found in the protocol.

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalized myasthenia gravis GMG Myasthenia gravis Myasthenia gravis, generalized

Contacts and locations

Locations

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36, Greece

  • AP-HM- Hôpital de La Timone

    Marseille, 13386, France

  • AP-HP - Hôpital de la Pitié Salpétrière

    Paris, 75013, France

  • AZ Sint-Lucas Gent

    Ghent, 9000, Belgium

  • Aarhus Universitetshospital

    Aarhus, 8200, Denmark

  • BayCare - St. Anthony's Hospital

    St. Petersburg, Florida, 33705-1410, United States

  • CHU de Nice-Hôpital Pasteur

    Nice, 06000, France

  • CLINIREM Sp z o.o.

    Lublin, 20-883, Poland

  • Centrum Medyczne Neurologia Slaska

    Katowice, 40-689, Poland

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Cluj County Emergency Clinical Hospital

    Cluj-Napoca, 400012, Romania

  • Cyprus Institute of Neurology and Genetics

    Égkomi, 2371, Cyprus

  • Desai Sethi Medical Center

    Miami, Florida, 33136, United States

  • Duke University School of Medicine - Duke Early Phase Clinical Research Unit

    Durham, North Carolina, 27710, United States

  • Eginitio Hospital

    Athens, 115 28, Greece

  • Erlanger Neuroscience Institute

    Chattanooga, Tennessee, 37403-2173, United States

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • First Choice Neurology Boca Raton

    Boca Raton, Florida, 33428, United States

  • First Hospital of Shanxi Medical University

    Taiyuan, 030001, China

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Genge Partners Inc.

    Montreal, H4A 3T2, Canada

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, 518053, China

  • Haukeland Universitetssykehus

    Bergen, 5021, Norway

  • Heritage Medical Research Clinic

    Calgary, T2N 4Z6, Canada

  • HonorHealth Neurology - Bob Bove Neuroscience Institute

    Scottsdale, Arizona, 85251, United States

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28304, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • Hospital de Santo António - Unidade Local de Saúde de Santo António

    Porto, 4050-011, Portugal

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Hôpital Erasme

    Anderlecht, 1070, Belgium

  • Kansas University Medical Center - Kansas City

    Fairway, Kansas, 66205, United States

  • Katholisches Klinikum Bochum - St. Josef Hospital

    Bochum, 44791, Germany

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11211, Saudi Arabia

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow, 31-505, Poland

  • LLC Caucasus Medical Centre

    Tbilisi, 0186, Georgia

  • Leeds General Infirmary

    Leeds, LS1 3EX, United Kingdom

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • Loma Linda University Health

    Fresno, California, 93701-2234, United States

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065, Poland

  • Medsol Clinical Research Center Inc

    Port Charlotte, Florida, 33952, United States

  • National Guard Riyadh

    Riyadh, 14611, Saudi Arabia

  • National Neuromuscular Research Institute

    Austin, Texas, 78756, United States

  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

    Pardubice, 530 03, Czechia

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • New Hospitals

    Tbilisi, 0114, Georgia

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, 315041, China

  • Odense Universitetshospital

    Odense C, 5000, Denmark

  • Opsta bolnica MSB - Medicinski Sistemi Beograd

    Belgrade, 11000, Serbia

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, 424, Norway

  • Ottawa Hospital - Civic Campus

    Ottawa, K1H 8L6, Canada

  • Panthera Biopartners

    Glasgow, G51 4TY, United Kingdom

  • Petre Sarajishvili Institute of Neurology

    Tbilisi, 0112, Georgia

  • Pineo Medical Ecosystem

    Tbilisi, 0112, Georgia

  • Qilu Hospital of Shandong University

    Qingdao, 266035, China

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Rutgers-Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901-1962, United States

  • SFM Clinical Research LLC

    Boca Raton, Florida, 33487, United States

  • Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

    Budapest, 1082, Hungary

  • Sibiu Emergency County Clinical Hospital

    Sibiu, 550166, Romania

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chongqing, 400016, China

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-503, Poland

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016, China

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi, 530021, China

  • The First Affiliated Hospital of Guangzhou University Chinese Medicine

    Guangzhou, 510405, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Neurology Institute / Healthcare Innovations Institute - Coral Springs

    Coral Springs, Florida, 33067, United States

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Turun Yliopistollinen Keskussairaala

    Turku, 20540, Finland

  • ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisbon, 1349-019, Portugal

  • ULS de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1150-199, Portugal

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • University Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • University General Hospital ''ATTIKON''

    Chaïdári, 124 62, Greece

  • University General Hospital of Patras

    Pátrai, 265 04, Greece

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7025, United States

  • University of South Florida (USF) Health - Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50-556, Poland

  • Wellstar - Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • West Georgia Medical Center

    Kutaisi, 4600, Georgia

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.